FDA 510(k)

INTRODEUCE DOUBLE LUMEN INTRODUCER

K-Number: K001985 · 2001-01-25

Decision Date2001-01-25

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTRODEUCE DOUBLE LUMEN INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2001-01-25 under 510(k) number K001985. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODEUCE DOUBLE LUMEN INTRODUCER?

INTRODEUCE DOUBLE LUMEN INTRODUCER is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Cook, Inc.. The 510(k) number is K001985.

When did INTRODEUCE DOUBLE LUMEN INTRODUCER receive FDA 510(k) clearance?

INTRODEUCE DOUBLE LUMEN INTRODUCER received FDA 510(k) clearance on 2001-01-25, under 510(k) number K001985.

Who is the listed applicant for INTRODEUCE DOUBLE LUMEN INTRODUCER?

The FDA 510(k) record lists Cook, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRODEUCE DOUBLE LUMEN INTRODUCER?

The FDA product code for INTRODEUCE DOUBLE LUMEN INTRODUCER is DYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.